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Pygeum africanum for the treatment of patients with benign prostatic hyperplasia: a systematic review and quantitative meta-analysis.

  • 2000-12
  • The American journal of medicine 109(8)
    • A Ishani
    • R MacDonald
    • D Nelson
    • I Rutks
    • T J Wilt

Study Design

Type
Systematic Review
Sample size
n = 562
Population
men with symptomatic benign prostatic hyperplasia
Methods
systematic review and quantitative meta-analysis of randomized trials, with searches of Medline (1966 to 2000), Embase, Phytodok, the Cochrane Library, bibliographies, and contact with authors and drug companies; inclusion criteria: symptomatic BPH, P. africanum alone or in combination, placebo or other pharmacologic control, treatment duration ≥30 days; two investigators independently extracted data

Purpose

To conduct a systematic review and quantitative meta-analysis of the therapeutic efficacy and tolerability of Pygeum africanum in men with symptomatic benign prostatic hyperplasia.

Methods

Studies were identified through the search of Medline (1966 to 2000), Embase, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. Randomized trials were included if participants had symptomatic benign prostatic hyperplasia, the intervention was a preparation of P. africanum alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacologic therapies for benign prostatic hyperplasia, and treatment duration was at least 30 days. Two investigators independently extracted key data on design features, subject characteristics, and therapy allocation.

Results

A total of 18 randomized controlled trials involving 1,562 men met the inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Only 1 of the studies reported a method of treatment allocation concealment, although 17 were double-blinded. The mean study duration was 64 days (range 30 to 122). Compared with placebo in 6 studies, P. africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI): -1.4 to -0.3]). Summary estimates of individual outcomes were also improved by P. africanum. Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19% and residual urine volume by 24%; peak urine flow was increased by 23%. Adverse effects due to P. africanum were mild and similar to placebo. The overall dropout rate was 12% and was similar for P. africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls).

Conclusions

The literature on P. africanum for the treatment of benign prostatic hyperplasia is limited by the short duration of studies and the variability in study design, the use of phytotherapeutic preparations, and the types of reported outcomes. However, the evidence suggests that P. africanum modestly, but significantly, improves urologic symptoms and flow measures. Further research is needed using standardized preparations of P. africanum to determine its long-term effectiveness and ability to prevent complications associated with benign prostatic hyperplasia.

Research Insights

  • Pygeum Bark→Improved Overall IBS Symptoms

    Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1).

    Effect
    Beneficial
    Effect size
    Large
  • Pygeum Bark→Improved Urinary Flow

    Compared with placebo in 6 studies, P. africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI): -1.4 to -0.3]).

    Effect
    Beneficial
    Effect size
    Moderate
  • Pygeum Bark→Increased Peak Urine Flow

    peak urine flow was increased by 23%

    Effect
    Beneficial
    Effect size
    Small
  • Pygeum Bark→Reduced Nocturia

    Nocturia was reduced by 19%

    Effect
    Beneficial
    Effect size
    Small
  • Pygeum Bark→Reduced Residual Urine Volume

    residual urine volume by 24%

    Effect
    Beneficial
    Effect size
    Small

Adverse Events Reported

  • Pygeum Bark→dropout

    The overall dropout rate was 12% and was similar for P. africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls).

    Finding
    No significant difference
    Magnitude
    13% (P. africanum), 11% (placebo), 8% (other controls); P = 0.4 versus placebo
    Significant
    No
  • Pygeum Bark→Overall tolerability

    Adverse effects due to P. africanum were mild and similar to placebo.

    Finding
    Reported
    Grade
    mild
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